Skip to content

Study of effect of treatment versus no treatment on seizures, psychological, behavioral and EEG parameters in children with BECTS type of epilepsy

A multicentric, randomized, prospective, open-labelled study to compare the effects of “treatment ? versus “no treatment ? on neuropsychological and electro-clinical parameters in Indian children with newly diagnosed BECTS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/012248
Enrollment
150
Registered
2018-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Children suffering from Benign Epilepsy with centro-temporal spikes ( BECTS)

Interventions

Intervention1: Treatment with antiepileptic drug Valproate: Valproate would be started to patients randomized to treatment group Control Intervention1: No treatment: Patients randomized to no treatmen

Sponsors

Bharati Vidyapeeth Medical College Pune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Onset of seizures after the age of 3 years 2. History of at least one typical seizure 3. Normal neurological and development history 4.Clinical and EEG criteria suggestive of BECTS according to ILAE criteria 5. No other seizure type

Exclusion criteria

Exclusion criteria: 1. Prior neurological deficits 2. Pre-existing psychiatric conditions 3. Symptomatic etiology 4. 3 or more seizures in last 3 months 5. Already on anti-epileptics for more than a week

Design outcomes

Primary

MeasureTime frame
To compare the changes in cognition ( IQ), language, behavior and academic achievement of children with newly diagnosed BECTS, between the no treatment group versus the Treatment group; from baseline to follow up over 2 years.Timepoint: 3 monthly till 2 years

Secondary

MeasureTime frame
i) To study the clinical and the EEG profile in these children at baseline and further till 2 years ii) To compare the seizure recurrence rates between the two groups iii) To monitor for any adverse effects related to the drug (in treatment group). Timepoint: 3 monthly till 2 years

Countries

India, United Arab Emirates

Contacts

Public ContactDr Kavita Srivastava

Bharati Vidyapeeth Medical College, Pune

kavisri1970@gmail.com9850825791

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026